Clinical Evaluation Of Remote Monitoring With Direct Alerts To Reduce Time From Event To Clinical Decision (REACT)

CLINICAL EVALUATION OF REMOTE MONITORING WITH DIRECT ALERTS TO REDUCE TIME FROM EVENT TO CLINICAL DECISION. (REACT Study)

St. Jude Medical developed the Merlin.net™ Patient Care Network (Merlin.net™ PCN) to augment or replace routine scheduled in-clinic visits.

This investigation is designed with the hypothesis that detection of events (system integrity and diagnostic related) through Direct Alerts™ via Remote Monitoring allow clinicians an earlier opportunity to address and resolve events and may therefore improve patient care.

Study Overview

• Status: Completed
• Conditions: The Patient Meets ACC/AHA/ESC Guidelines for Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) Device
• Intervention / Treatment: Device: Implantation of an ICD/CRT-D device; Device: Merlin.NET PCN

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Ludwigsburg, Germany
    • Dr. Ralph Bosch
• United Kingdom
  • Newcastle, United Kingdom, NE7 7DN
    • Freeman Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient meets ACC/AHA/ESC guidelines for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT-D) device
• The patient is recently (≤2 weeks) implanted with a SJM device compatible with the Merlin.net™ PCN - (inclusive of upgrade from ICD to CRT-D or an implantable pulse generator change)
• The patient has a life expectancy of greater than 12 months (based on the physician's discretion).
• The patient is mentally capable to participate in the investigation (based on the physician's discretion).
• The patient is 18 years of age or older

Exclusion Criteria:

• The patient is being actively considered for cardiac transplantation.
• The patient has primary valvular disease that has not been corrected.
• The patient had a myocardial infarction within the last month
• The patient had unstable angina within the last month.
• The patient has had Coronary Artery Bypass Grafting (CABG) within the last month.
• The patient had a Percutaneous Coronary Angioplasty (PTCA) within the last month.
• The patient is pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Direct Alerts ON; Direct Alerts in implantable device were turned on	Device: Implantation of an ICD/CRT-D device; The Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) device and leads are not the devices being evaluated in this investigation.; Other Names: The SJM ICD family of devices with the Invisilink feature are the AnalyST™ and /AnalyST Accel™ and Current™/CurrentTM RF/Current AccelTM.; The SJM CRT-D family of devices with the Invisilink feature is the Promote™/PromoteTM RF.; Device: Merlin.NET PCN; The Merlin.Net™ PCN is a dedicated computer system that connects physicians to patients outside of the clinic setting by centralizing data from remote transmissions, implant procedures and in-clinic follow-ups into single location with easy export to Electronic Health Record (EHR) systems; Other Names: Merlin.NET
Active Comparator: Direct Alerts OFF; Direct Alerts in implantable device were turned off	Device: Implantation of an ICD/CRT-D device; The Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) device and leads are not the devices being evaluated in this investigation.; Other Names: The SJM ICD family of devices with the Invisilink feature are the AnalyST™ and /AnalyST Accel™ and Current™/CurrentTM RF/Current AccelTM.; The SJM CRT-D family of devices with the Invisilink feature is the Promote™/PromoteTM RF.; Device: Merlin.NET PCN; The Merlin.Net™ PCN is a dedicated computer system that connects physicians to patients outside of the clinic setting by centralizing data from remote transmissions, implant procedures and in-clinic follow-ups into single location with easy export to Electronic Health Record (EHR) systems; Other Names: Merlin.NET

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time between the detection of an event and the point in time when the physician or delegate takes a clinical decision	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
The sufficiency of the device data retrieved through the Remote Monitoring feature to make a clinical decision	2 years
The physician or delegate time required for remote follow up as compared to in-clinic follow up	2 years
The changes over one year in the Hospital Anxiety and Depression Scale (HADS) for the two different randomization arms	2 years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Janet McComb, MD, Freeman Hospital Newcastle; UK

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: March 18, 2010
• First Submitted That Met QC Criteria: March 18, 2010
• First Posted (Estimate): March 19, 2010

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: ICD, CRTD, Remote Care
• Other Study ID Numbers: CR-09-064-WW-RC